Evidence-based informed consent forms for total knee arthroplasty and anaesthesia: development and pilot study

Area of Science:

• Medical Ethics
• Health Communication
• Surgical Patient Care

Background:

• Standard informed consent forms for total knee arthroplasty (TKA) often lack evidence-based content, hindering informed decision-making.
• There is a need for improved informed consent processes in elective surgical procedures.

Purpose of the Study:

• To develop and pilot test an evidence-based informed consent form for TKA.
• To enhance patient understanding and support shared decision-making in TKA.

Main Methods:

• A two-phase study involving the development of extended, evidence-based informed consent forms and an e-learning program.
• Systematic evidence syntheses, expert reviews, and patient pilot testing through think-aloud interviews and focus groups were employed.
• Qualitative content analysis was used to analyze patient and expert feedback for iterative revisions.

Main Results:

• Evidence-based informed consent forms for TKA and anesthesia were developed, adhering to evidence-based guidelines and legal requirements.
• Forms presented benefits and complications using natural frequencies and visualizations, and were rated as understandable and helpful by patients.
• An e-learning program and a revised knowledge test were developed to support clinician training and patient comprehension.

Conclusions:

• Evidence-based informed consent forms for TKA are feasible and positively perceived by patients.
• Patient feedback highlighted the importance of personalized counseling and structural adjustments for optimal use.
• The developed forms and associated training tools can improve the informed consent process in TKA.